Thoracic aortic stent graft deployment device

• US 6,939,370 B2
• Filed: 06/30/2003
• Issued: 09/06/2005
• Est. Priority Date: 06/28/2002
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated), William A. Cook Australia Pty. Ltd (Cook Group Incorporated), William Cook Europe ApS (Cook Group Incorporated)
• Inventors: Huffer, Leigh Anthony, Hartley, David Ernest
• Primary Examiner(s): Pellegram, Brian E
• Assistant Examiner(s): Prone, Christopher
• Application Number:
  US10/609,846
• Publication Number:
  US 20040098079A1
• Time in Patent Office: 799 Days
• Field of Search: 623/1.11, 606/198, 606/195, 606/191, 606/194, 606/108, 604/104
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod

Abstract

A stent graft deployment device adapted for release of a distal end (29) of a stent graft (25) before the proximal end (27) of the stent graft (25). The arrangement (15) allows movement of at least part of the deployment catheter (23) independently of movement of a proximal end release mechanism has a fixed handle (16) associated with a trigger wire release mechanism (6) and a sliding handle (17) to which the deployment catheter and a capsule (21) are fixed. The sliding handle (17) is mounted on the fixed handle (16) and can slide longitudinally with respect to the fixed handle (16).

Claims

1. A stent graft deployment device which holds a stent graft in a retained condition and arranged to release of a distal end of a stent graft before the proximal end of the stent graft, the device having a proximal stent graft end release mechanism and a distal stent graft end release mechanism associated with a deployment catheter and an arrangement to allow movement of at least part of the deployment catheter including the distal stent graft end release mechanism independent of movement of the proximal stent graft end release mechanism wherein the distal end release mechanism associated with the deployment catheter includes a capsule for engaging the distal end of the stent graft or a distally extending exposed stent on the stent graft and the arrangement to allow movement of at least part of the deployment catheter independently of movement of the proximal end release mechanism includes a fixed handle associated with a trigger wire release mechanism and a sliding handle to which the deployment catheter and the capsule are fixed.

2. A stent graft deployment device as in claim 1 wherein the proximal end release mechanism includes at least one proximal trigger wire.

3. A stent graft deployment device as in claim 1 wherein the distal end release mechanism includes a distal trigger wire.

4. A stent graft deployment device as in claim 3 including an arrangement to remove the distal trigger wire at the distal end of the stent graft before removing the distal exposed stent capsule.

5. A stent graft deployment device as in claim 1 further including a sheath over the deployment catheter to cover the stent graft during initial deployment with the sheath being actuatable by a sheath manipulator slidably received onto the deployment catheter and wherein movement of the sheath manipulator on the deployment catheter will move the sheath with respect to the deployment catheter to expose the stent graft.

6. A stent graft deployment device as in claim 1 wherein the sliding handle is mounted on the fixed handle and can slide longitudinally with respect to the fixed handle.

7. A stent graft deployment device as in claim 1 further including a locking arrangement which prevents movement of the sliding handle with respect to the fixed handle.

8. A stent graft deployment device as in claim 7 wherein the locking arrangement comprises a thumbscrew fixed to the sliding handle which engages against a portion of the fixed handle to prevent inadvertent or early movement of the sliding handle with respect to the fixed handle and wherein the thumbscrew can be removed when it is desired to move the sliding handle.

9. A stent graft deployment device as in claim 1 further including a lock mechanism which prevents the sliding handle from being moved forward after an initial movement back.

10. A stent graft deployment device as in claim 9 wherein the lock mechanism is provided by a spring loaded pin or plunger mechanism on one of the fixed handle or the sliding handle which engages the other of the fixed or sliding handles and allows movement of the deployment catheter from the position where the capsule on the deployment catheter is engaged onto the exposed stents to a position where the deployment catheter is disengaged and wherein at that time the spring loaded pin mechanism engages a recess in the other of the fixed or sliding handles to prevent further movement.

11. A stent graft deployment device as in claim 1 further including a hemostatic seal associated with the fixed handle to prevent loss of blood between the fixed handle and the sliding handle.

12. A stent graft deployment device as in claim 11 wherein the hemostatic seal includes a guide tube fixed onto the deployment catheter and sliding into a central lumen in the fixed handle with an O-ring in the fixed handle engaging around the guide tube.

13. A stent graft deployment apparatus comprising:

a deployment catheter having a proximal end adapted to be introduced into

a patient and a distal end adapted to remain outside a patient, the distal end including a handle arrangement, the catheter having at a proximal end thereof a region adapted in use to contain a stent graft;

a sheath arrangement adapted in use to extend over and cover the region adapted to be moved with respect to the catheter to expose the region to thereby enable deployment of the stent graft;

a nose cone dilator positioned at the proximal end of the deployment catheter;

a distal retention arrangement for the stent graft at a distal end of the region and comprising a proximally facing capsule having a passageway and adapted to retain the distal end of a stent graft;

the handle arrangement including a fixed handle and a sliding handle, at least the capsule being affixed to the sliding handle, whereby movement of the sliding handle with respect to the fixed handle moves the capsule independent of movement of the nose cone dilator.

14. A stent graft deployment apparatus comprising:

a deployment catheter having a proximal end adapted to be introduced into a patient and a distal end adapted to remain outside a patient, the distal end including a handle arrangement;

a longitudinal lumen through the deployment catheter;

a guide wire catheter extending through the longitudinal lumen and extending proximally of the deployment catheter, the guide wire catheter having a proximal end and a distal end; and

the guide wire catheter being movable longitudinally and rotationally with respect to the deployment catheter;

a nose cone dilator being attached to a proximal end of the guide wire catheter and extending proximally thereof;

a sheath arrangement adapted in use to cover at least a portion of the deployment catheter and to extend to the nose cone dilator and adapted to be moved with respect to the catheter to enable deployment of a stent graft retained on the deployment device;

a distal retention arrangement for the stent graft at a proximal end of the deployment catheter and comprising a proximally facing capsule having a passageway and adapted to retain a distal end of a stent graft;

the handle arrangement including a fixed handle and a sliding handle, the deployment catheter and the capsule being affixed to the sliding handle, whereby movement of the sliding handle with respect to the fixed handle moves the deployment catheter and the capsule independent of movement of the nose cone dilator.

15. A stent graft deployment apparatus as in claim 14 including a proximal retention arrangement on the guide wire catheter distal of the nose cone dilator for the proximal end of the stent graft.

16. A stent graft deployment apparatus as in claim 15 wherein the proximal retention arrangement includes at least one proximal trigger wire.

17. A stent graft deployment apparatus as in claim 16 wherein the proximal trigger wire extends from the outside of the patient where it is retained by a trigger wire release mechanism on the fixed handle.

18. A stent graft deployment apparatus as in claim 14 wherein the distal retention arrangement includes an aperture extending through the capsule and a distal trigger wire extending along the deployment catheter and extendable through the aperture.

19. A stent graft deployment apparatus as in claim 18 the distal trigger wire extends from the outside of the patient where it is retained by a trigger wire release mechanism on the fixed handle.

20. A stent graft deployment device as in claim 14 wherein the sliding handle is mounted on the fixed handle and can slide longitudinally with respect to the fixed handle.

21. A stent graft deployment device as in claim 20 further including a locking arrangement which prevents movement of the sliding handle with respect to the fixed handle.

22. A stent graft deployment device as in claim 21 wherein the locking arrangement comprises a thumbscrew fixed to the sliding handle which engages against a portion of the fixed handle to prevent inadvertent or early movement of the sliding handle with respect to the fixed handle and wherein the thumbscrew can be removed when it is desired to move the sliding handle.

23. A stent graft deployment device as in claim 14 further including a lock mechanism which prevents the sliding handle from being moved forward after an initial movement back.

24. A stent graft deployment device as in claim 23 wherein the lock mechanism is provided by a spring loaded pin or plunger mechanism on one of the fixed handle or the sliding handle which engages the other of the fixed or sliding handles and allows movement of the deployment catheter from the position where the capsule on the deployment catheter is engaged onto the exposed stents to a position where the deployment catheter is disengaged and wherein at that time the spring loaded pin mechanism engages a recess in the other of the fixed and sliding handles to prevent further movement.

25. A stent graft deployment device as in claim 14 further including a hemostatic seal associated with the fixed handle to prevent loss of blood between the fixed handle and the sliding handle.

26. A stent graft deployment device as in claim 25 wherein the hemostatic seal includes a guide tube fixed onto the deployment catheter and sliding into a central lumen in the fixed handle with an O-ring in the fixed handle engaging around the guide tube.